Halyard MINI PLUS KIT SOUTH Recalled Due to Organ Transplant Unsuitability
AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is FDA Class I classified, which mandates a minimum severity score of 4 (Severe) per the rubric. The source does not report any deaths or injuries that would elevate the classification further.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08). The recall involves 380 units with UDI 10809160462829 and Lot Number 1654185.
The FDA determined that the devices are not suitable for organ transplant procedures. Healthcare providers should review their inventory and identify any affected units.
The recalled devices were distributed in Florida, Georgia, and Puerto Rico.
Any facility in possession of these devices should discontinue use in organ transplant procedures. Contact AVID Medical, Inc. or the FDA for further instructions regarding device return or disposal.
The recalled product
- Product
- Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
- Manufacturer
- AVID Medical, Inc.
- Hazard
- device-unsuitable-for-transplant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Kit Code: JACK097-08
- UDI : 10809160462829
- Lot No: 1654185.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27